Package leaflet: Information for the user • you are taking other medicines which may cause hearing

• you are taking other medicines which may cause hearing • water tablets (such as furosemide) - also called ‘diuretics’ • Maintenance dose: 6 mg for every kilogram of body Children (from 2 months to 12 years)
1. What Targocid is and what it is used for problems and/or kidney problems. You may have which may cause hearing problems and/or kidney problems. weight, given once a day, by injection into a vein or
® 200 mg powder for • Starting dose (for the first three doses): 10 mg for every
Targocid is an antibiotic. It contains a medicine called regular tests to check if your kidneys and/or liver are If any of the above apply to you, (or you are not sure), talk muscle kilogram of body weight, given every 12  hours, by
solution for injection/infusion or oral solution working properly (see ‘Other medicines and Targocid’). to your doctor, pharmacist or nurse before being given Bone and joint infections, and heart infections injection into a vein.
® 400 mg powder for ‘teicoplanin’. It works by killing the bacteria that cause
infections in your body. If any of the above apply to you (or you are not sure), talk to Targocid. • Starting dose (for the first three to five doses): 12 mg for • Maintenance dose: 6 to 10  mg for every kilogram of
solution for injection/infusion or oral solution Targocid is used in adults and children (including newborn your doctor, pharmacist or nurse before you are given Pregnancy, breast-feeding and fertility every kilogram of body weight, given every 12 hours, by body weight, given once a day, by injection into a vein.
teicoplanin babies) to treat bacterial infections of: Targocid. If you are pregnant, think that you might be pregnant or injection into a vein
• Maintenance dose: 12 mg for every kilogram of body How Targocid is given
- the skin and underneath the skin - sometimes called Tests are planning to have a baby, ask your doctor, pharmacist or
weight, given once a day, by injection into a vein or The medicine will normally be given to you by a doctor or
‘soft tissue’ During treatment you may have tests to check your blood, nurse for advice before being given this medicine. They will
muscle nurse.
- the bones and joints your kidneys and/or your hearing. This is more likely if: decide whether or not you are given this medicine while
Infection caused by ‘Clostridium difficile’ bacteria • It will be given by injection into a vein (intravenous use)
Is this leaflet hard to see or read? - the lung • your treatment will last for a long time you are pregnant. There may be a potential risk of inner ear
and kidney problems. The recommended dose is 100 to 200 mg by mouth, twice or muscle (intramuscular use).
Phone 0845372 7101 for help - the urinary tract • you have a kidney problem • It can also be given as a infusion through a drip into a
- the heart - sometimes called ‘endocarditis’ • you are taking or may take other medicines that may Tell your doctor if you are breast-feeding, before being a day for 7 to 14 days.
▼ This medicine is subject to additional monitoring. This - the abdominal wall - peritonitis affect your nervous system, kidneys or hearing. given this medicine. He/she will decide whether or not you
can keep breast-feeding, while you are given Targocid.
Adults and elderly patients with kidney problems
If you have kidney problems, your dose will usually need to
vein.
Only the infusion should be given in babies from birth to
will allow quick identification of new safety information. - the blood, when caused by any of the conditions listed In people who are given Targocid for a long time, bacteria
Studies in animal reproduction have not shown evidence of be lowered after the fourth day of treatment: the age of 2 months.
You can help by reporting any side effects you may get. See above that are not affected by the antibiotic may grow more than
fertility problems. • For people with mild and moderate kidney problems - To treat certain infections, the solution may be taken by
the end of section 4 for how to report side effects. Targocid can be used to treat some infections caused by normal - your doctor will check for this.
the maintenance dose will be given every two days, or mouth (oral use).
Read all of this leaflet carefully before you are given ‘Clostridium difficile’ bacteria in the gut. For this, the solution Driving and using machines
Other medicines and Targocid half of the maintenance dose will be given once a day. If you have more Targocid than you should
this medicine because it contains important information is taken by mouth. You may have headaches or feel dizzy while being treated
Tell your doctor, pharmacist or nurse if you are using, have • For people with severe kidney problems or on It is unlikely that your doctor or nurse will give you too
for you. with Targocid. If this happens, do not drive or use any tools
2. What you need to know before you are recently used or might use any other medicines. This is haemodialysis - the maintenance dose will be given every much medicine. However, if you think you have been given
- Keep this leaflet. You may need to read it again. or machines.
given Targocid because Targocid can affect the way some other medicines three days, or one-third of the maintenance dose will be
Targocid contains sodium too much Targocid or if you are agitated, talk to your
- If you have any further questions, ask your doctor, work. Also, some medicines can affect the way Targocid works. given once a day.
pharmacist or nurse. Do not use Targocid if: This medicine contains less than 1 mmol sodium (23 mg) doctor or nurse straight away.
In particular, tell your doctor, pharmacist or nurse if you are Peritonitis for patients on peritoneal dialysis
- If you get any side effects, talk to your doctor, pharmacist • you are allergic to teicoplanin or any of the other taking the following medicines: per vial and is essentially ‘sodium-free’. If you forget to have Targocid
The starting dose is 6 mg for every kilogram of body weight,
or nurse. This includes any possible side effects not listed ingredients of this medicine (listed in section 6). • Aminoglycosides as they must not be mixed together Your doctor or nurse will have instructions about when to
3. How to use Targocid as a single injection into a vein, followed by:
give you Targocid. It is unlikely that they will not give you
in this leaflet. See section 4. Warnings and precautions with Targocid in the same injection. They may also cause • Week one: 20 mg/L in each dialysis bag
What is in this leaflet Talk to your doctor, pharmacist or nurse before you are hearing problems and/or kidney problems. The recommended dose is • Week two: 20 mg/L in every other dialysis bag the medicine as prescribed. However, if you are worried,
1. What Targocid is and what it is used for given Targocid if: • amphotericin B - a medicine that treats fungal infections Adults and children (12 years and over) with no kidney • Week three: 20 mg/L in the overnight dialysis bag. talk to your doctor or nurse.
2. What you need to know before you are given Targocid • you are allergic to an antibiotic called ‘vancomycin’ which may cause hearing problems and/or kidney problems problems Babies (from birth to the age of 2 months) If you stop having Targocid
3. How to use Targocid • you have had a flushing of your upper part of your body • ciclosporin - a medicine that affects the immune system Skin and soft tissue, lung and urinary tract infections • Starting dose (on the first day): 16 mg for every kilogram Do not stop having this medicine without first talking to
4. Possible side effects (red man syndrome) which may cause hearing problems and/or kidney problems • Starting dose (for the first three doses): 6 mg for every of body weight, as an infusion through a drip into a vein. your doctor, pharmacist or nurse.
5. How to store Targocid • you have a decrease in platelet count (thrombocytopenia) • cisplatin - a medicine that treats malignant tumors which kilogram of body weight, given every 12 hours, by • Maintenance dose: 8 mg for every kilogram of body weight, If you have any further questions on the use of this
6. Contents of the pack and other information • you have kidney problems may cause hearing problems and/or kidney problems injection into a vein or muscle given once a day, as an infusion through a drip into a vein. medicine, ask your doctor, pharmacist or nurse.

CROMinFOTO s.n.c. Tel.

Via G. Tartini, 2 2 0 1 5 8 - M I L A N O
-
02.375787 • e-mail: crominfoto@tiscali.it 89034682
(int. version 1) 28 MAG 2019
GRAFICA - FOTOCOMPOSIZIONE AZIENDA CERTIFICATA UNI EN ISO 9001:2015

TYPE OF MATERIAL: DESCRIPTION: COUNTRY: LOGO VERSION: MIN. FONT SIZE:/LINE SPACING:
LEAFLET FOLDED TARGOCID 200 MG & 400 MG UK A1 8.7 pt.
CODE: VERSION: OLD CODE: DIE CUT: DIMENSIONS mm: COLOURS N°: COLOUR 1:
89034682 89032880
757200 1 a 709162 I011 420 x 148 (210 x 148) 1 BLACK
 • difficulty in breathing or wheezing (bronchospasm) Reporting of side effects What Targocid looks like and contents of the pack The following information is intended for medical or • Ringer-lactate solution
4. Possible side effects
• getting more infections than usual - these could be signs If you get any side effects, talk to your doctor, pharmacist or Targocid is a powder for solution for injection/infusion or healthcare professionals only: • 5% dextrose injection
Like all medicines, this medicine can cause side effects, of a decrease in your blood cell count nurse. This includes any possible side effects not listed in oral solution. Practical information for healthcare professionals on • 10% dextrose injection
although not everybody gets them. Not known (frequency cannot be estimated from the this leaflet. The powder is spongy, ivory and coloured homogeneous mass. preparation and handling of Targocid. • 0.18% sodium chloride and 4% glucose solution
Serious side effects available data) The powder is packaged: • 0.45% sodium chloride and 5% glucose solution
United Kingdom This medicine is for single use only.
• lack of white blood cells - the signs may include: fever, • Peritoneal dialysis solution containing 1.36% or 3.86%
Stop your treatment and tell your doctor or nurse You can also report side effects directly via the Yellow Card • in a Type I, colourless glass vial of useful volume of 10 mL Method of administration
severe chills, sore throat or mouth ulcers (agranulocytosis) glucose solution.
straight away, if you notice any of the following serious Scheme at: www.mhra.gov.uk/yellowcard or search for for 200 mg closed with bromobutyl rubber stopper and The reconstituted solution may be injected directly or
• kidney problems or changes in the way your kidneys MHRA Yellow Card in the Google Play or Apple App Store. Shelf life of reconstituted solution
side effects - you may need urgent medical treatment: plastic flip-off top aluminium yellow overseal. alternatively further diluted.
work - shown in tests Chemical and physical in-use stability of the reconstituted
Uncommon (may affect up to 1 in 100 people) Malta • in a Type I, colourless glass vial of useful volume of 22 mL The injection will be given either as a bolus over 3 to 5
• epileptic fits solution prepared as recommended has been demonstrated
• sudden life-threatening allergic reaction - the signs may You can also report side effects directly via ADR Reporting for 400 mg closed with bromobutyl rubber stopper and minutes or as a 30-minutes infusion.
Tell your doctor or nurse straight away, if you notice any of for 24 hours at 2 to 8°C.
include: difficulty in breathing or wheezing, swelling, www.medicinesauthority.gov.mt/adrportal plastic flip-off top aluminium green overseal. Only the infusion should be given in babies from birth to
the side effects above. From a microbiological point of view, the medicine should
rash, itching, fever, chills By reporting side effects you can help provide more the age of 2 months.
Other side effects Pack size: be used immediately. If not used immediately, in-use storage
Rare (may affect up to 1 in 1000 people) information on the safety of this medicine. The reconstituted solution may also be given by mouth.
Talk to your doctor, pharmacist or nurse if you get any of - 1 powder vial times and conditions prior to use are the responsibility of the
• flushing of the upper body Preparation of reconstituted solution user and would normally not be longer than 24 hours at 2 to
these: 5. How to store Targocid - 5x1 powder vials
The solution is reconstituted by adding 3.14 mL of water for 8°C, unless reconstitution has taken place in controlled and
Not known (frequency cannot be estimated from the available Common (may affect up to 1 in 10 people) - 10x1 powder vials
injection to the 200 mg and 400 mg powder vial. The water validated aseptic conditions.
data) • Rash, erythema, pruritus Keep this medicine out of the sight and reach of children. - 25x1 powder vials is slowly added to the vial which should be rotated until all
• blistering of the skin, mouth, eyes or genitals - these • Pain Do not use this medicine after the expiry date which is Not all pack sizes may be marketed. Shelf life of diluted medicine
the powder is dissolved to avoid foaming. If foam is developed,
may be signs of something called ‘toxic epidermal • Fever stated on the carton and label of the vial after EXP. The Chemical and physical in-use stability of the reconstituted
Marketing Authorisation Holder and Manufacturer allow the solution to stand for approximately 15 minutes so
necrolysis’ or ‘Stevens-Johnson syndrome’ or ‘drug expiry date refers to the last day of that month. solution prepared as recommended has been demonstrated
Uncommon (may affect up to 1 in 100 people) that the foam disappears.
reaction with eosinophilia and systemic symptoms This medicine does not require any special storage conditions. Marketing Authorisation Holder for 24 hours at 2 to 8°C.
• decrease in platelet count. Only clear and yellowish solutions should be used.
(DRESS)’. DRESS appears initially as flu-like symptoms Information about storage and the time to use Targocid, Sanofi, 410 Thames Valley Park Drive, From a microbiological point of view, the medicine should
• raised blood levels of liver enzymes The final solution is isotonic with plasma and has a pH of
and a rash on the face then an extended rash with a high after it has been reconstituted and is ready to use, are Reading, Berkshire, RG6 1PT, UK. be used immediately. If not used immediately, in-use storage
• raised in blood levels of creatinine (to monitor your kidney) 7.2-7.8.
temperature, increased levels of liver enzymes seen in described in the ‘Practical information for healthcare Tel: 0845372 7101 times and conditions prior to use are the responsibility of
• hearing loss, ringing in the ears or a feeling that you, or Nominal teicoplanin content of vial 200 mg 400 mg
blood tests and an increase in a type of white blood cell professionals on preparation and handling of Targocid’. email: uk-medicalinformation@sanofi.com the user and would normally not be longer than 24 hours at
things around you are moving
(eosinophilia) and enlarged lymph nodes. Volume of powder vial 10 mL 22 mL 2 to 8°C, unless reconstitution/dilution has taken place in
• feeling or being sick (vomiting), diarrhoea 6. Contents of the pack and other Manufacturer
Tell your doctor or nurse straight away, if you notice any of controlled and validated aseptic conditions.
• feeling dizzy or headache information Sanofi S.p.A., Via Valcanello 4 Volume containing nominal
the side effects above. Disposal
Rare (may affect up to 1 in 1,000 people) 03012 Anagni (FR), Italy teicoplanin dose (extracted by
Tell your doctor or nurse straight away, if you notice Any unused medicine or waste material should be disposed
• infection (abscess). What Targocid contains 5 mL syringe and 23 G needle) 3.0 mL 3.0 mL
any of the following serious side effects - you may need This medicinal product is authorised in the Member of in accordance with local requirements.
Not known (frequency cannot be estimated from the • The active substance is teicoplanin. Each vial contains Preparation of the diluted solution before infusion
urgent medical treatment: either 200 mg or 400 mg teicoplanin. States of the EEA under the following names:
available data) Targocid can be administered in the following infusion solutions:
• The other ingredients are sodium chloride and sodium Denmark, Finland, Norway, Sweden, United Kingdom: Targocid
Uncommon (may affect up to 1 in 100 people) • problems where the injection was given - such as • sodium chloride 9 mg/mL (0.9%) solution 89034682
• swelling and clotting in a vein reddening of the skin, pain or swelling hydroxide. This leaflet was last revised in 07/2019. • Ringer solution 757200

CROMinFOTO s.n.c. Tel.

Via G. Tartini, 2 2 0 1 5 8 - M I L A N O
-
02.375787 • e-mail: crominfoto@tiscali.it 89034682
(int. version 1) 28 MAG 2019
GRAFICA - FOTOCOMPOSIZIONE AZIENDA CERTIFICATA UNI EN ISO 9001:2015

TYPE OF MATERIAL: DESCRIPTION: COUNTRY: LOGO VERSION: MIN. FONT SIZE:/LINE SPACING:
LEAFLET FOLDED TARGOCID 200 MG & 400 MG UK A1 8.7 pt.
CODE: VERSION: OLD CODE: DIE CUT: DIMENSIONS mm: COLOURS N°: COLOUR 1:
89034682 89032880
757200 1 a 709162 I011 420 x 148 (210 x 148) 1 BLACK